Jackie Cahill (Tipperary, Fianna Fail)
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367. To ask the Minister for Health if the drug romosozumab will shortly be regulated by the Health Products Regulatory Authority in Ireland and be made available on the drug payment scheme and to medical card holders, given that this drug is used to treat osteoporosis in many countries; and if he will make a statement on the matter. [5689/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines and medical items, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the formal Reimbursement list. Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). The Minister for Health has no role in these decisions.

The HSE received an application on the 20 April 2021 for pricing and reimbursement of Romosozumab (Evenity®), which is indicated for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Phamacoeconomics (NCPE) for assessment. The HSE commissioned the Rapid Review process on the 21 April 2021.

The NCPE Rapid Review assessment report was received by the HSE on the 27 May 2021. A full health technology assessment (HTA) was recommended to assess the clinical effectiveness and cost effectiveness of Romosozumab (Evenity®) compared with the current standard of care. The HSE commissioned a full HTA on the 28 June 2021 as per agreed processes.

The NCPE publishes details of medicines where the HSE has commissioned a Rapid Review assessment and/or a full HTA assessment on their website. The website is updated at regular intervals and includes assessment outcomes and updates on reimbursement for each individual medicine and indication listed.

Details of the assessment(s) of Romosozumab (Evenity®) are available at:www.ncpe.ie/drugs/romosozumab-evenity-hta-id-21016/.

The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications.

The HSE Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members.

The pharmacoeconomic report will be reviewed by the HSE Drugs Group along with the outputs of commercial negotiations, and any patient group submission(s) received. The HSE Drugs Group will consider all of the evidence and make a recommendation to the HSE Executive Management Team. Therefore, the application for Romosozumab (Evenity®) remains under consideration.